The conference will bring together
leaders in industry (Pharma and CRO), academia, quality assurance and
regulatory authorities to discuss established concepts and recent thinking on
regulated bioanalysis. The scientific program is currently under development and will
comprise of presentations by and discussions with experts from around the
globe. The conference program will include topics as:

With
scientific developments and regulatory expectations not always in concert, our
3rd Focus Meeting aims to connect on the potential of a broad array
of new technologies. We will provide a scientific hub for the development of
strategies, which may enable the application of these emerging technologies to
their full potential in regulated bioanalysis.

Session 1 - Miniaturization and/or automation of sample
preparation techniques
This session will focus on recent progress made in automation and/or
miniaturization in support of (regulated) bioanalytical sample preparation.
This includes but is not limited to liquid handling technologies, micro
extraction and chip technologies. The goal of this session is to share and
discuss techniques and processes that will facilitate the sample preparation
workflow.

Session 2 - How can antibody technology help with sample
enrichment for NCE or peptides quantification?
This session will focus the use of antibody capture techniques used to optimise
sample enrichment for Pharmocokinetic and Pharmacodynamic endpoint
technologies.

Afternoon plenary sessions:
Recent developments in tissue analysis

Session 3 - Tissue analysis (including micro sampling) and
PK/PD
Over the last years, the analytical potential offered by modern MS technology
or immunological approaches opened new
avenues in the analysis of non standard matrices for PK, TK or PK/PD reasons.
In this session we invite scientist to share their experience or observed
scientific, analytical or regulatory hurdles when applying these new
technologies. Both MS and LBA scientist will be welcomed.

Session 4 - Is Tissue Imaging approaching quantitative
bioanalysis expectations
The goal of this session is to highlight & discuss the advances and
current/potential future use of Tissue Imaging approaches as quantitative
bioanalytical tools in a regulated environment.

Session 5 - Miniaturization of LC using ‘conventional’
MS Ionization techniques
Advances made in LC miniaturization, such as microbore and capillary LC, CE,
and chip techniques, is opening new possibilities for the bioanalytical
scientist. Together with these new possibilities come new challenges. In this
session, thoughts and experiences with these techniques will be shared with the
aim to enhance the toolset in the (regulated) bioanalytical laboratory and
improve problem solving capability.

Session 6 - Alternative MS-interfaces for quantitative
bioanalysis
The last 5 years may have been one of the most exciting periods for the
bioanalytical scientist with (historically less robust) alternative
MS-interfaces (to the commonly used ESI
and APCI) coming available to their fullest potential for quantitative
bioanalysis. In this session, we aim at providing examples of these alternative
MS-interfaces and want to stimulate discussions to enhance their application in
(regulated) quantitative bioanalysis.

Morning
Breakout Sessions: Emerging platforms in support of LBA

Session 7 - Recent new technologies – Methodologies
As the industry looks at options beyond traditional single-plate ELISAs to achieve greater dynamic ranges, analyze
multiple analytes or exploit new reporting systems; what are the technology
options available (e.g. Flow Cytometry, multiplex analysers etc)? The goal of
this session is to showcase & discuss the emerging new LBA technologies
& novel LBA methodologies for use in a regulated bioanalysis setting.

Session 8 - Recent new technologies – Applications and
validation approaches
How are methods being validated on new technology platforms? This session aims
to identify and discuss best practices for the validation package requirements
of novel LBA applications - are these bespoke or can traditional ELISA method
validation packages be used?

Afternoon plenary session:
Global Bioanalysis Consortium Updates

Session 9 - GBC feedback session
Discuss and provide feedback on the progress made in global harmonization of
the bioanalysis guidelines (GBC). The intention is to invite 4-5 Harmonization
team leads (or a regional representative from those teams) to present the
progress of their teams and to engage with delegates for input and feedback.

About the EBF

The European Bioanalysis Forum (EBF) is an organisation comprised of bioanalytical scientists working within the pharmaceutical industry R&D. The scope of EBF is on regulated bioanalysis of small and large molecules.We discuss on regulatory issues and aspects (new guidelines, interpretation of existing guidelines) and present our joint opinion towards regulatory bodies and our peers.